Adynxx Completes Enrollment in Phase 1 Clinical Study of Lead Therapeutic for Treatment of Pain, AYX1

SAN FRANCISCO, Aug. 7, 2012 /PRNewswire/ -- Adynxx, a clinical stage pharmaceutical company developing a first-in-class platform of therapeutics to address pain at its molecular roots, announced today the completion of enrollment in the Phase 1 clinical study in healthy volunteers of its lead investigational drug candidate for the prevention of acute and chronic post-surgical pain, AYX1.

"The Adynxx therapeutic platform a novel approach to treating and preventing pain has the potential to transform pain management," said Dennis Podlesak, chairman of the Adynxx board of directors. "The clinical development of this breakthrough technology is being driven by an accomplished management team that has a track record of success that includes building successful biotech companies and attaining multiple new drug approvals. The Adynxx team is well positioned to achieve our goal of developing these exciting new treatment options for preventing pain."

The 30 subject, dose-escalating study is currently evaluating AYX1 in five cohorts of healthy volunteers. Later this year, Adynxx plans to move into a proof-of-concept Phase 2 clinical study assessing the ability of a single administration of AYX1 at the time of surgery to reduce acute pain, prevent the transition to persistent post-surgical pain and consequently improve functional recovery.

"Despite many years of investigation and development, effective relief of post-surgical pain remains a challenge for the millions of patients who undergo surgery every year," said Rick Orr, president and chief executive officer of Adynxx. "Given the urgent need for new treatment options for post-surgical pain, we are excited to have advanced the AYX1 development program at such a rapid pace since the company's founding. With enrollment complete, we look forward to receiving and evaluating the unblinded safety data later this quarter. This will allow us to initiate a Phase 2 efficacy study in the coming months."

Added Donald C. Manning, M.D., Ph.D., chief medical officer of Adynxx, "Therapeutics currently available to physicians and patients address pain as a symptom and often only as it arises. While we believe that these established therapeutics have a place in treatment of pain, we are interested in developing transformative options for those who seek to treat pain as a preventable and ultimately curable disease."

The AYX therapeutic platform was designed by Julien Mamet, Ph.D., founder and chief scientific officer of Adynxx, to specifically address a significant unmet need in pain therapy: providing long-term pain relief with a one-time treatment. It acts by simultaneously neutralizing complementary and redundant molecular mechanisms that maintain pain over time. Long-term efficacy of AYX1 after a single administration has been demonstrated in a variety of preclinical pain and functional assessment models. In addition to AYX1, Adynxx is advancing a pipeline of therapeutics for treatment of other indications, including chronic lower back pain and intractable neuropathic and inflammatory pain syndromes.

About Adynxx

Adynxx, located in San Francisco, California, is a clinical stage pharmaceutical company developing a transformative technology platform addressing pain at its molecular roots - preventing the development of pain following surgery or trauma and resolving established chronic pain syndromes. Adynxx's unique approach is to transform pain management by approaching pain as a disease rather than a symptom.

Adynxx's lead compound, AYX1, is an investigational drug designed to prevent acute post-surgical pain and the transition to persistent or chronic pain with a single administration at the time of surgery. Adynxx has completed enrollment in a Phase 1 clinical trial of AYX1 and plans to initiate a Phase 2 study of AYX1 in Q4 2012. AYX2, intended to resolve multiple forms of chronic lower back pain, is currently in pre-clinical development along with additional compounds intended to target a range of intractable neuropathic and inflammatory pain syndromes. For more information, visit www.adynxx.com.